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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5226 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 5226

    To establish a program to address sickle cell disease and other 
                     heritable hemoglobinopathies.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           September 25, 2024

 Mr. Van Hollen (for himself and Mr. Booker) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
    To establish a program to address sickle cell disease and other 
                     heritable hemoglobinopathies.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Sickle Cell Disease Treatment 
Centers Act of 2024''.

SEC. 2. ESTABLISHMENT OF SICKLE CELL DISEASE AND OTHER HERITABLE 
              HEMOGLOBINOPATHIES TREATMENT CENTERS.

    Subpart I of part D of title III of the Public Health Service Act 
(42 U.S.C. 254b et seq.) is amended by inserting after section 330P (42 
U.S.C. 254c-22) the following:

``SEC. 330Q. SICKLE CELL DISEASE AND OTHER HERITABLE HEMOGLOBINOPATHIES 
              TREATMENT CENTERS.

    ``(a) Definitions.--In this section:
            ``(1) Community-based organization.--The term `community-
        based organization' means a community-based nonprofit 
        organization.
            ``(2) Hub-and-spoke network.--The term `hub-and-spoke 
        network' means a system for delivery of health care services--
                    ``(A) in which a medical hub identifies and manages 
                a medical spoke or network of spokes, to provide 
                comprehensive sickle cell disease care;
                    ``(B) in which such entities serving as spokes--
                            ``(i) may provide sickle cell disease care 
                        services; and
                            ``(ii) may increase services over time to 
                        meet the definition of medical hubs and connect 
                        with new spokes; and
                    ``(C) in which the medical hub and spoke has a 
                partnership with one or more community-based 
                organizations to extend services and outreach to the 
                sickle cell disease community.
            ``(3) Medical hub.--The term `medical hub' means a 
        hospital, clinic, or university health center that--
                    ``(A) provides comprehensive sickle cell disease 
                treatment, which may include medical and surgical 
                treatment, such as provision of stem cell transplants 
                and cell and gene therapies, an outpatient treatment 
                clinic led by a board-certified hematologist, infusion 
                capability, telehealth capability, genetic counseling, 
                access to home care, and a pharmacy;
                    ``(B) has experience serving individuals living 
                with sickle cell disease or other hemoglobinopathies;
                    ``(C) follows consensus-based clinical practice 
                guidelines; and
                    ``(D) may be a grantee or coordinate with grantees 
                of the Sickle Cell Disease Treatment Demonstration 
                Program under section 1106(b).
            ``(4) Spoke.--The term `spoke' means an entity--
                    ``(A) that provides health care services, 
                including--
                            ``(i) a Federally-qualified health center, 
                        as defined in section 1905(l)(2)(B) of the 
                        Social Security Act;
                            ``(ii) a hospital, clinic, or university 
                        health center that provides clinical care and 
                        has telehealth capability;
                            ``(iii) a primary care provider;
                            ``(iv) an outpatient treatment clinic;
                            ``(v) an infusion center; or
                            ``(vi) other health care providers;
                    ``(B) that has at least 1 collaborative agreement 
                with a medical hub and one or more community-based 
                organization; and
                    ``(C) that incorporates a community health worker 
                into the care team.
    ``(b) Program Established.--The Secretary shall award grants to 
eligible entities to establish treatment centers using a hub-and-spoke 
framework (referred to in this section as `Sickle Cell Disease 
Treatment Centers'), for the purposes of--
            ``(1) promoting access to coordinated, lifelong health care 
        for all patients with sickle cell disease;
            ``(2) providing support to establish integrated health care 
        teams for patients with sickle cell disease over a patient's 
        lifetime;
            ``(3) improving the health and well-being of children, 
        youth, and adults with sickle cell disease;
            ``(4) improving the pediatric-to-adult health care 
        transition;
            ``(5) collecting and contributing clinical data from States 
        participating in the Sickle Cell Data Collection program of the 
        Centers for Disease Control and Prevention, including the 
        collection of health outcomes and associated complications 
        reported pursuant to such program;
            ``(6) ensuring that reporting with respect to sickle cell 
        disease includes reporting on all patients with sickle cell 
        disease, including migrating and foreign-born patients; and
            ``(7) conducting significant public health awareness and 
        education activities with respect to sickle cell disease and 
        sickle cell trait.
    ``(c) Eligible Entity.--The term `eligible entity' means any entity 
that is comprised of--
            ``(1) a hub-and-spoke network that includes--
                    ``(A) a medical hub that is a hospital, clinic, or 
                university health center; and
                    ``(B) at least 1 spoke working in partnership with 
                the medical hub; and
            ``(2) at least 1 community-based nonprofit organization 
        working in a partnership with the hub-and-spoke network.
    ``(d) Use of Funds by Eligible Entities.--An eligible entity shall 
use grant funds received under this section as follows:
            ``(1) Medical hub.--The medical hub of the eligible entity 
        shall carry out the following:
                    ``(A) Operating and administrating costs of 
                operating a hub-and-spoke framework.
                    ``(B) Complying with consensus-based sickle cell 
                disease treatment guidelines, as identified by the 
                Secretary.
                    ``(C) Educating health care providers on sickle 
                cell disease treatment standards and protocols.
                    ``(D) Providing integrated care management, which 
                may include--
                            ``(i) primary care;
                            ``(ii) specialty care;
                            ``(iii) pain management;
                            ``(iv) mental health services;
                            ``(v) genetic counseling services; and
                            ``(vi) other providers.
                    ``(E) Coordinating specialty care services, whether 
                provided at the medical hub or spoke.
                    ``(F) Coordinating reproductive health and family 
                planning services for patients with sickle cell 
                disease, trait, or other hemoglobinopathies.
                    ``(G) Providing a dedicated sickle cell expert at 
                the medical hub to assist in overseeing care of sickle 
                cell disease patients at spokes and to advise the 
                community-based organization.
                    ``(H) Educating health care providers on social 
                determinants of health and implicit bias that may 
                affect quality of care and life for patients with 
                sickle cell disease, trait, or other 
                hemoglobinopathies.
                    ``(I) Providing telehealth appointments to patients 
                when appropriate and facilitating access to telehealth 
                services for sickle cell disease patients to the extent 
                feasible.
                    ``(J) Implementing pediatric-to-adult health care 
                transition programs for purposes of ensuring 
                coordinated patient graduation from pediatric to adult 
                providers for all patients.
                    ``(K) Providing social work services or community 
                health worker services in coordination with one or more 
                community-based organizations.
                    ``(L) Collecting and distributing data as required 
                by the National Sickle Cell Disease Coordinating Center 
                established under subsection (f) or otherwise required 
                by the Secretary.
                    ``(M) Engaging in quality improvement with respect 
                to such standards of care for health and quality of 
                life outcomes among sickle cell disease patients as the 
                Secretary may require.
            ``(2) Community-based organization.--The community-based 
        organization of the eligible entity shall provide or coordinate 
        services to patients and families, which may include the 
        following:
                    ``(A) Providing education and outreach to 
                individuals at-risk for sickle cell trait, individuals 
                with sickle cell trait, sickle cell disease patients, 
                caregivers, and health care providers.
                    ``(B) Providing support in addressing social 
                determinants of health, such as food insecurity, 
                housing insecurity, and access to education and 
                transportation.
                    ``(C) Providing social work services or community 
                health worker services in coordination with a medical 
                hub or spoke.
                    ``(D) Testing or coordinating testing for 
                individuals at-risk for sickle cell trait and 
                individuals with sickle cell trait that increase the 
                likelihood of having a child with sickle cell disease, 
                including through coordination with a genetic 
                counselor.
                    ``(E) Engaging in quality improvement with respect 
                to standards of care or health and quality of life 
                outcomes among sickle cell disease patients, as 
                identified by the Secretary.
            ``(3) Spoke.--The spokes of the eligible entity shall 
        provide or coordinate each of the following services:
                    ``(A) Collaborating with a medical hub to 
                coordinate and support care for sickle cell disease 
                patients.
                    ``(B) Providing standards of care as developed in 
                coordination with the medical hub.
                    ``(C) Providing primary care services, genetic 
                counseling, or specialty care.
                    ``(D) Providing telehealth appointments, as 
                appropriate.
                    ``(E) Providing medical or surgical treatment.
                    ``(F) Implementing individual care plans.
                    ``(G) Providing social work services or community 
                health worker services in coordination with one or more 
                community-based organizations.
                    ``(H) Collecting and distributing data as required 
                by the National Sickle Cell Disease Coordinating Center 
                established under subsection (f).
            ``(4) Additional uses of funds.--In addition to the uses of 
        funds described in paragraphs (1), (2), and (3), an eligible 
        entity selected to receive a grant under this section may use 
        funds received through the grant--
                    ``(A) to identify and secure resources for ensuring 
                reimbursement under, for the State involved, the State 
                plan under title XIX of the Social Security Act (or a 
                waiver of such plan), State child health plan under 
                title XXI of such Act (or a waiver of such plan), and 
                other health programs for the prevention and treatment 
                of sickle cell disease, including by working with 
                community-based sickle cell disease organizations and 
                other nonprofit entities;
                    ``(B) to assist sickle cell disease patients with 
                accessing appropriate health insurance, including--
                            ``(i) through the payment of insurance 
                        premiums and cost-sharing amounts, to the 
                        extent otherwise permitted under State and 
                        Federal law;
                            ``(ii) by working with community-based 
                        sickle cell disease organizations and other 
                        nonprofit entities; and
                            ``(iii) by helping sickle cell disease 
                        patients know their rights with insurance 
                        programs;
                    ``(C) to facilitate access to telehealth services 
                for sickle cell disease patients and individuals with 
                sickle cell trait, to the extent feasible;
                    ``(D) to fund evidence-based programs that provide 
                education to health care providers, teachers and school 
                personnel, and correctional institutional personnel, on 
                the care of individuals with sickle cell disease or 
                trait in health care settings and other appropriate 
                settings, including schools and prisons;
                    ``(E) to develop a system of social and community 
                supports, including transportation services or travel 
                reimbursement for sickle cell disease patients who do 
                not have, but who need access to, in-person care with 
                the Sickle Cell Disease Treatment Centers; and
                    ``(F) to facilitate access to sickle cell trait 
                testing and genetic counseling.
    ``(e) Application; Selection.--
            ``(1) Application.--An eligible entity desiring a grant 
        under this section shall submit an application to the Secretary 
        at such time, in such manner, and containing such information 
        as the Secretary may require, including a description of how 
        the hub-and-spoke entity and community-based organization will 
        collaborate in carrying out the activities described in 
        subsection (c).
            ``(2) Geographic distribution.--The Secretary shall award 
        grants under this section, to the extent practicable, to 
        eligible entities, with a focus on regions where a 
        disproportionate number of patients with sickle cell disease, 
        individuals with sickle cell trait, or other heritable 
        hemoglobinopathy patients per capita reside, and to eligible 
        entities nationwide so that patients can access more 
        comprehensive sickle cell disease treatment services no matter 
        where they reside.
            ``(3) Priorities in making awards.--In awarding grants 
        under this section, the Secretary may give priority to eligible 
        entities that--
                    ``(A) include at least one historically black 
                college or university (defined as a part B institution 
                under section 322 of the Higher Education Act of 1965 
                (20 U.S.C. 1061)) or minority serving institution 
                (defined as an eligible institution under section 371 
                of such Act (20 U.S.C. 1067q)) that has a medical 
                school, nursing school, nurse practitioner or physician 
                assistant program, genetic counseling program, or 
                school of social work;
                    ``(B) serve an area with a high prevalence of 
                sickle cell disease; or
                    ``(C) serve a rural area.
    ``(f) National Sickle Cell Disease Coordinating Center.--
            ``(1) In general.--The Secretary shall establish, or enter 
        a cooperative agreement with an entity to establish, the 
        National Sickle Cell Disease Coordinating Center, which shall 
        coordinate the activities conducted by grantees under this 
        section and carry out the activities described in paragraph 
        (2).
            ``(2) Duties.--The National Sickle Cell Disease 
        Coordinating Center shall carry out each of the following 
        activities:
                    ``(A) Advise the Secretary on the design and 
                implementation of, and coordinate the infrastructure 
                of, the Sickle Cell Disease Treatment Centers 
                established under subsection (b), including with 
                respect to administrative requirements and ensuring 
                that sickle cell health care is available across the 
                United States.
                    ``(B) Develop a national strategy for the practice 
                of equitable care, coordinated comprehensive quality 
                care, research and resources for patients and health 
                care providers, and treatment modality options to 
                improve patient outcomes, and submit such national 
                strategy to the Secretary.
                    ``(C) Coordinate with Federal agencies to improve 
                data collection over the lifespan of patients and 
                routinely update a national needs assessment to improve 
                care for individuals impacted by sickle cell disease.
                    ``(D) Coordinate with hub-and-spoke networks, 
                patients, researchers, and health care providers to 
                maintain a comprehensive sickle cell research, 
                treatment, and national care strategy.
                    ``(E) Establish a rotating panel of stakeholders, 
                including health care providers, patients, individuals 
                impacted by sickle cell disease, allied health 
                professionals, care coordinators, social workers, 
                community health workers, and sickle cell community-
                based and advocacy organizations to advise the Center, 
                provide up-to-date information and forecasts on status 
                and plans for improving sickle cell care, treatment, 
                and access to treatment modalities for individuals and 
                families living with sickle cell disease.
                    ``(F) Coordinate and support hub-and-spoke 
                frameworks.
                    ``(G) Support improvement in patient and family-
                centered care, health outcomes, and care affordability 
                by improving access to care.
                    ``(H) Provide or coordinate technical assistance 
                and support to health care providers, family members 
                and advocates, public health professionals, 
                policymakers, and patients that want to improve access 
                to quality care, telemedicine, family planning, health 
                care transition, and family and community engagement.
                    ``(I) Inform and educate the public about sickle 
                cell disease, sickle cell trait, and options for 
                quality care.
    ``(g) CDC Sickle Cell Disease Data Collection Program for SCD 
Treatment Centers.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, in coordination with the 
National Sickle Cell Coordinating Center established under subsection 
(f), shall carry out the following:
            ``(1) Collecting, coordinating, monitoring, and 
        distributing data, best practices, and findings regarding the 
        activities funded under grants made to eligible entities under 
        this section.
            ``(2) Collecting and maintaining up-to-date data on sickle 
        cell disease, including subtypes as applicable, and their 
        associated health outcomes and complications, in consultation 
        with States participating in the Sickle Cell Data Collection of 
        the Centers for Disease Control and Prevention, including for 
        the purpose of--
                    ``(A) improving national incidence and prevalence 
                data, including the geographic distribution of affected 
                individuals;
                    ``(B) identifying health disparities impacting 
                individuals born with sickle cell disease, including 
                subtypes as applicable, and other hemoglobinopathies;
                    ``(C) assessing the utilization of therapies, 
                comprehensive complication risk screening, and 
                strategies to prevent complications resulting from 
                sickle cell disease and to increase quality of life; 
                and
                    ``(D) evaluating the effects of genetic, 
                environmental, behavioral, and other risk factors that 
                may affect individuals with sickle cell disease.
            ``(3) Developing educational materials, public awareness 
        campaigns, or other outreach programs regarding the inheritance 
        pattern, treatment of, and prevention of complications from 
        sickle cell disease and prevalence of sickle cell trait, as 
        well as programs and activities that will enhance the lives of 
        individuals living with sickle cell disease and sickle cell 
        disease trait.
    ``(h) Request for Information.--Not later than 180 days after the 
date of enactment of the Sickle Cell Disease Treatment Centers Act of 
2024, and in advance of each new grant cycle thereafter, the Secretary 
shall publish in the Federal Register a request for information seeking 
feedback from stakeholders on--
            ``(1) best practices with respect to the establishment and 
        implementation of Sickle Cell Disease Treatment Centers; and
            ``(2) any other information that the Secretary may require.
    ``(i) Report to Congress.--
            ``(1) In general.--Not later than 3 years after the date of 
        the enactment of the Sickle Cell Disease Treatment Centers Act 
        of 2024 and every 5 years thereafter, the Secretary shall 
        submit to the Committee on Health, Education, Labor, and 
        Pensions and the Committee on Appropriations of the Senate and 
        the Committee on Energy and Commerce and the Committee on 
        Appropriations of the House of Representatives a report on the 
        impact of the Sickle Cell Disease Treatment Centers established 
        under this section on health outcomes for sickle cell disease 
        patients.
            ``(2) Report elements.--The report described in this 
        section shall include--
                    ``(A) a summary and description of eligible 
                entities operating a hub-and-spoke system that are 
                receiving grant funds under this section;
                    ``(B) information about the specific activities 
                supported by grant funds awarded under this section 
                with respect to each eligible entity;
                    ``(C) the number of sickle cell disease patients 
                served by grant programs funded under this section and 
                demographic information about those patients, including 
                race, sex, gender, geographic location, and age; and
                    ``(D) information about patient experiences with 
                the hub-and-spoke system and community-based 
                organizations.
    ``(j) Supplement, Not Supplant.--The activities under this section 
shall supplement, not supplant, otherwise authorized activities of the 
Department of Health and Human Services relating to sickle cell 
disease.
    ``(k) Authorization of Appropriations.--
            ``(1) In general.--To carry out this section, there are 
        authorized to be appropriated such sums as may be necessary for 
        fiscal year 2025 and each fiscal year thereafter.
            ``(2) Allocation to activities.--Of the amount appropriated 
        under paragraph (1) for a fiscal year--
                    ``(A) 70 percent may be awarded to eligible 
                entities for purposes of supporting the activities of 
                hub and spoke networks that are a part of such eligible 
                entities;
                    ``(B) 20 percent may be awarded to eligible 
                entities for purposes of supporting the activities of 
                community-based organizations that are a part of such 
                eligible entities;
                    ``(C) 5 percent may be used for the establishment 
                and maintenance of the National Sickle Cell Disease 
                Coordinating Center described in subsection (f); and
                    ``(D) 5 percent may be used for the activities of 
                the Sickle Cell Data Collection program of the Centers 
                for Disease Control and Prevention described in 
                subsection (g).''.
                                 <all>
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